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Device Nerve Procedure for Lung Blood Pressure in Heart Failure Patients

Tests a device-based nerve procedure in heart failure patients with pulmonary hypertension.

Plain-language title generated from the registry record
Registry title: Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)

Key facts

Where
Badalona, Barcelona, and Valencia, SpainSee the 3 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with heart failure and a type of high blood pressure in the lungs (pulmonary hypertension group 2). It studies a device treatment that targets nerves around the lung artery.

Age
22 to 85 years
Sex
All sexes can join.
Disease stage
Heart failure with pulmonary hypertension. Mean pulmonary artery pressure above 20 mmHg at rest. Pulmonary vascular resistance of 3WU or more at rest. Pulmonary capillary wedge pressure above 15 mmHg at rest, or above 18 with passive leg raise. NYHA Class II or III.
Earlier treatment
No CRT, ICD, pacemaker or other heart procedure (except right heart catheterization) in the last 3 months.
Biomarker or test result
Kidney function (GFR) of 25 ml/min or more.

Main reasons for not taking part

  • Life expectancy under 2 years
  • Cannot take dual antiplatelet drugs or anticoagulants, or allergic to aspirin or clopidogrel
  • Cannot tolerate right heart catheterization
  • Severe aortic, mitral or pulmonary valve regurgitation
  • Clot in the target treatment area of the pulmonary artery

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 22 and 85 years old?

Source: NCT06495970, who can take part

Where in Spain

  • Hospital Universitari Germans Trias i PujolBadalona, SpainContact: Julie EtheridgeTaking people
  • Hospital Universitari Vall d'HebronBarcelona, SpainContact: Julie EtheridgeTaking people
  • Hospital Clinico Universitario de ValenciaValencia, SpainContact: Julie EtheridgeTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Gradient Denervation Technologies
Trial code
NCT06495970
Record updated
1 August 2025
Original description
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary HypertensionRead full original descriptionShow less

Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)

Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Inclusion: Mean Pulmonary Artery Pressure (mPAP) >20 mmHg at rest; Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest; Pulmonary Capillary Wedge Pressure > 15 mmHg (at rest) or > 18 with passive leg raise; NYHA Class II or III; Glomerular Filtration Rate (GFR) ≥ 25 ml/min.

Exclusion: Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel; Unable to tolerate right heart catheterization; Systemic infection or localized infection/rash at planned access site at time of procedure; CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) within the last 3 months; Life expectancy of < 2 years; Unwilling to provide informed consent or complete follow-up assessments; Severe aortic, mitral or pulmonary valve regurgitation; Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery).

ClinicalTrials.gov NCT06495970